uniQure N.V. (NASDAQ:QURE – Get Free Report)’s share price fell 4.4% during mid-day trading on Thursday . The company traded as low as $44.17 and last traded at $44.1810. 452,545 shares changed hands during trading, a decline of 81% from the average daily volume of 2,365,216 shares. The stock had previously closed at $46.23.
More uniQure News
Here are the key news stories impacting uniQure this week:
- Positive Sentiment: uniQure submitted a Biologics License Application (BLA) to the FDA seeking accelerated approval for AMT-130, a major step toward commercialization. The company also filed a Marketing Authorisation Application with the U.K. MHRA, broadening its potential market opportunity. uniQure Announces Submission of Biologics License Application
- Positive Sentiment: The FDA filing is eligible for Priority Review, which could reduce the review period to six months after the agency’s initial 60-day filing review—although Priority Review has been requested, not yet granted. AMT-130 also has FDA Breakthrough Therapy, RMAT and Fast Track designations. uniQure seeks U.S. approval for Huntington’s gene therapy
- Positive Sentiment: The applications rely on three-year Phase I/II data indicating slower disease progression versus an external natural-history control. uniQure expects to present four-year data before the end of the third quarter, providing another potential catalyst. uniQure, after setbacks, seeks FDA approval
- Positive Sentiment: William Blair resumed coverage with an Outperform rating and a $73 fair-value estimate, adding Wall Street support following the regulatory update. uniQure FDA filing and analyst commentary
- Neutral Sentiment: The regulatory submission follows a significant FDA shift from previously seeking a larger randomized study to accepting an accelerated-approval filing, creating both substantial upside potential and elevated binary-event volatility.
- Negative Sentiment: The FDA and U.K. regulators must still accept or validate the applications and could determine that the Phase I/II evidence is insufficient. Accelerated approval, if granted, may also require costly confirmatory studies.
- Negative Sentiment: Reported insider activity shows repeated sales and no purchases over the past six months, which may temper investor confidence after the recent rally.
Analyst Upgrades and Downgrades
QURE has been the subject of several research reports. Leerink Partners lifted their price objective on shares of uniQure from $36.00 to $70.00 and gave the stock an “outperform” rating in a research note on Thursday, June 18th. The Goldman Sachs Group upped their target price on uniQure from $14.00 to $46.00 and gave the company a “neutral” rating in a research report on Thursday, June 18th. Weiss Ratings restated a “sell (e+)” rating on shares of uniQure in a research note on Friday, June 26th. Cantor Fitzgerald raised uniQure from a “neutral” rating to an “overweight” rating and set a $61.00 price target for the company in a research report on Wednesday, June 17th. Finally, Wolfe Research upgraded uniQure from a “peer perform” rating to an “outperform” rating and set a $65.00 price target on the stock in a research note on Wednesday, July 29th. Fourteen equities research analysts have rated the stock with a Buy rating, two have issued a Hold rating and one has assigned a Sell rating to the company’s stock. According to data from MarketBeat.com, uniQure currently has an average rating of “Moderate Buy” and a consensus price target of $65.00.
uniQure Trading Down 2.8%
The firm has a market cap of $3.12 billion, a price-to-earnings ratio of -11.17 and a beta of 0.94. The company has a fifty day moving average price of $44.45 and a 200-day moving average price of $30.07. The company has a current ratio of 10.01, a quick ratio of 10.01 and a debt-to-equity ratio of 0.15.
uniQure (NASDAQ:QURE – Get Free Report) last posted its earnings results on Wednesday, July 29th. The biotechnology company reported ($1.22) EPS for the quarter, missing the consensus estimate of ($0.82) by ($0.40). The company had revenue of $5.84 million for the quarter, compared to analyst estimates of $5.45 million. uniQure had a negative return on equity of 111.96% and a negative net margin of 1,350.73%.During the same period last year, the business earned ($0.69) earnings per share. As a group, research analysts expect that uniQure N.V. will post -3.74 EPS for the current year.
Insider Activity
In other uniQure news, CEO Matthew C. Kapusta sold 21,082 shares of the firm’s stock in a transaction that occurred on Thursday, July 2nd. The stock was sold at an average price of $45.16, for a total value of $952,063.12. Following the sale, the chief executive officer directly owned 519,227 shares of the company’s stock, valued at approximately $23,448,291.32. This trade represents a 3.90% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Madhavan Balachandran sold 11,685 shares of uniQure stock in a transaction on Wednesday, June 17th. The shares were sold at an average price of $45.06, for a total transaction of $526,526.10. Following the completion of the sale, the director directly owned 43,254 shares in the company, valued at $1,949,025.24. This represents a 21.27% decrease in their position. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold 385,584 shares of company stock worth $16,737,722 over the last 90 days. Company insiders own 4.65% of the company’s stock.
Institutional Investors Weigh In On uniQure
Institutional investors have recently bought and sold shares of the company. Seven Fleet Capital Management LP acquired a new stake in shares of uniQure in the second quarter worth approximately $15,254. IFP Advisors Inc purchased a new stake in shares of uniQure in the fourth quarter valued at about $48,000. Smartleaf Asset Management LLC purchased a new stake in shares of uniQure in the 4th quarter valued at approximately $48,000. CIBC Private Wealth Group LLC acquired a new position in uniQure in the third quarter valued at approximately $50,000. Finally, Ensign Peak Advisors Inc grew its position in uniQure by 21.7% in the fourth quarter. Ensign Peak Advisors Inc now owns 3,650 shares of the biotechnology company’s stock worth $87,000 after acquiring an additional 650 shares during the period. 78.83% of the stock is currently owned by institutional investors and hedge funds.
uniQure Company Profile
uniQure N.V. is a biotechnology company focused on the development and commercialization of gene therapies for patients with severe medical needs. Using its proprietary adeno?associated viral (AAV) vector platform, the company designs single?dose treatments aimed at addressing the underlying genetic causes of disease rather than solely managing symptoms. Its most advanced program, Hemgenix® (etranacogene dezaparvovec), received regulatory approval in the United States and Europe for adult patients with hemophilia B, marking one of the first gene therapies for a bleeding disorder to reach the market.
Beyond hemophilia B, uniQure’s pipeline includes preclinical and clinical-stage candidates targeting rare and debilitating conditions such as aromatic l-amino acid decarboxylase (AADC) deficiency, Huntington’s disease, and Parkinson’s disease.
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